Efficacy and Safety Study of Xyotax to Treat Prostate Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine whether Xyotax, a conjugate of the taxane drug paclitaxel, is effective in the treatment of prostate cancer that is no longer responsive to hormone therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Methodist Hospital Research Institute; The Methodist Hospital System
• Collaborator: Cellular Therapeutics
• Treatments: Paclitaxel; Paclitaxel poliglumex

Criteria

Inclusion Criteria:

• Progressing adenocarcinoma of the prostate having failed prior hormone therapy

• Free of serious co-morbidity

• Have a life expectancy of ≥ 24 weeks

• Maintaining castrate status (either surgically or hormonally)

Exclusion Criteria:

• Patients with central nervous system metastases, except those patients who have had excision or radiotherapy and remain asymptomatic, off steroids and with no evidence of disease as shown by MRI for at least 6 months

• Patients known to be HIV positive

• Patients with active autoimmune disease

• Patients involving concurrent anticancer drug therapy

• Patients with unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months)